FDA: New Contraindication, Updated Warning for Reclast

Label change to Reclast reflects risk of renal toxicity

FRIDAY, Sept. 2 (HealthDay News) -- The drug label for Reclast (zoledronic acid) has been updated to reflect the risk of kidney failure, according to a safety alert issued Sept. 1 by the U.S. Food and Drug Administration.

The FDA has received reports of patients experiencing acute renal failure requiring dialysis and even dying after taking Reclast, used to treat or prevent osteoporosis. The new label warns that the drug is contraindicated in patients with evidence of acute renal impairment or creatinine clearance of less than 35 mL/min.

Patients who are at risk for renal failure include those who have moderate to severe renal impairment, those who use nephrotoxic or diuretic medications, and those who are severely dehydrated when receiving Reclast. The label change extends only to Reclast; the label for Zometa, used in the treatment of bone metastases in cancer patients, already includes information about the risk of kidney failure.

According to the FDA, "Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. [Health care professionals should] screen patients prior to administering Reclast in order to identify at-risk patients. Health care professionals should also monitor renal function in patients who are receiving Reclast."

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